Location: REMOTEDescription: REMOTE EXC Safety Specialist Summary:Responsible for general safety management, MedDRA coding, and management of clinical events adjudication on a clinical trial using an investigational drug.
This position will support major healthcare provider that completes Clinical Research Studies with outside clients.Will support study that is funded by government it’s a device study that is regulated by FDA and open for 5-6 years.
Large amount of adverse events and we need to do a final look of the whole set and ensure we’ve had consistency with coding (MedDRA coding)Assist with end of study review will compile all events with each site (100+ sites), and then work with sites directly to review each eventPrimary duties may include, but are not limited to: Establishes, executes, and maintains a Safety Management Plan (SMP) and Clinical Endpoint Committee (CEC) Charter, in collaboration with client(s).
Reviews and triages adverse events (AEs) including serious adverse events (SAEs) reported by sites as a part of a clinical trial according to SMP.
Codes adverse events, using MedDRA, in the electronic data capture (EDC) system.
Reviews SAE for administrative and medical consistency with other site-reported data; including requesting follow-up and clarification from sites.
Reconciles AEs/SAEs collected in the EDC with the client’s pharmacovigilance system.
Prepares adjudication event dossiers for CEC review and central adjudication.
Collaborates with team members in preparation for and potential attendance at CEC meetings.
Interacts with investigational sites and field monitors to obtain additional pertinent information as indicated.
Works with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.G.
SAEs, adverse events (AEs) and device deficiencies).
Serves as a liaison for safety related questions (e.G.
to study team, monitors and study sites).
Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms.
Maintains knowledge of current FDA CFR and ICH regulations and policies affecting clinical trials.
Prepares training materials and trains investigative sites and CEC members, and maintains documentation of training.
Assists with training on study specific adverse event definitions prior to start of clinical study and ongoing as needed to ensure compliance and accurate reporting.
Attends and participates in team calls.
Education and Skills:Requires BA/BS degree in a life sciences area or be a registered nurse2 + years of hands-on related safety experience in a clinical trial environment MedDRA coding experienceOR any combination of education and experience, which would provide an equivalent background.
BSN preferred.
MedDRA certification preferred.Please submit your resume or inquires to Matt Mabry at mmabry@judge.com or text to (484) 585-4078 Thank you.
Contact: mmabry@judge.comThis job and many more are available through The Judge Group.
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